5PSQ-044 Safety of pembrolizumab +/- chemotherapy in first-line metastatic non-small-cell lung carcinoma in real-world practice

Background and Importance Cancer patients with comorbidities are usually excluded from clinical trials. Real-life observational studies are of particular interest to elucidate the safety of these new therapies. Safety of pembrolizumab +/- chemotherapy in metastatic non-small-cell lung carcinoma (NSCLC) was assessed in KEYNOTE-024, 189 and 407 pivotal trials. Aim and Objectives To assess the safety of pembrolizumab +/- platinum-based chemotherapy in first-line treatment of metastatic NSCLC in real-world practice. Material and Methods Observational, retrospective, single-centre study including 130 adult patients with stage IV NSCLC treated in first-line from 1 December 2017 to 31 December 2022, without EGFR or ALK mutations, autoimmune diseases or brain metastases, and performance status 0–1. Patients with PD-L1 ≥ 50% received pembrolizumab 200 mg or 2 mg/kg IV every 3 weeks. Those with non-squamous histology and PD-L1 Results In total, 491 AE of any grade and 78 of grade 3–4 were recorded. 10 patients discontinued treatment due to toxicity. AEs with incidence > 15% were (any grade – grade 3–4): anaemia (36–11), anorexia (51–2), asthenia (96–10), nausea (43–3), diarrhoea (25 -2), constipation (20–0), mucositis (21–2), neurotoxicity (22–1). Immune-mediated AEs were (any grade – grade 3–4): hepatotoxicity (7–3), nephritis (3–1), myocarditis (1–1), duodenojejunitis (1–1), pneumonitis (1–0). Conclusion and Relevance Most patients suffered more than one AE. Even so, no deaths were related to toxicity (there were no grade 5 AEs). The six grade 3–4 immune-mediated AEs should be highlighted. References and/or Acknowledgements Conflict of Interest No conflict of interest.